This past year, brought about two important legislations, The Surrogacy (Regulation) Act, 2019 (SR Act) and The Assisted Reproductive Technology Act (ART Act), 2021, both intended to curb unethical surrogacy practices, and, to regulate assisted reproductive technology services, respectively.

The SR Act aims to regulate surrogacy practices in the country, by way of establishment of several authorities at the central and state levels, for effective monitoring and adjudication. In this regard, it determines the scope of surrogacy, rights available to intending parents and surrogates, protocol to be followed by medical institutions and medical professionals, along with the establishments of such board/authorities.

Complementing the SR Act, the ART Act also focuses on regulation and supervision of assisted technology banks/clinics to prevent any misuse or unethical practices while providing such facilities. The ART Act specifies functions and duties of the boards, medical institutions i.e., clinics and banks, and sets out the process of regulation with respect to reproductive material (gametes, embryos, embryonic tissues, and other such related aspects). The impact of these legislations on the booming assisted reproductive technology and domestic commercial surrogacy industry has been analysed over the course of this Article.

Boon or Bane?

At the outset, the Acts have taken a positive approach towards preventing sex selection by mandating strict compliance by medical institutions and other stakeholders, with non – compliance resulting in heavy fines. However, certain loopholes exist, which have been discussed below –

1. Surrogacy procedures have been limited to altruistic purposes alone, placing strict prohibitions against commercialization. While this is a good step, however, this does not resolve the issue which concerns the women of the country and cannot be just looked at as a way of protection against exploitation of women. Currently, for the purposes of surrogacy, it was the economically weaker class which had become a palatable vessel, and this identified purpose under the new legislation, hits at this very thread, curtailing their right to livelihood. This is an additional burden to the economically downtrodden , since the SR Act imposes the added condition of being able to act as a surrogate only once . This could also be negating the constitutional right to life, which also includes the right to livelihood, of a woman who chooses to be a surrogate more than once. Where a woman is physically, mentally and medically fit to be a surrogate more than once, and more importantly chooses to be a surrogate again, this particular provision deters her from doing so. Possible implications of such a restriction could be the proliferation of illegal and unregulated black markets, which are far more dangerous to such individuals. However, it can be argued that the limitation is in line with regulations of different countries, such as Netherlands , United Kingdom , South Africa and Greece .

(1) Dr. Ranjana Kumari, Surrogate Motherhood – Ethical or Commercial, Centre for Social Research, pg. 40 onwards, accessed online at https://wcd.nic.in/sites/default/files/final%20report.pdf on 14.01.2022 at 1933 hours

(2) Refers to the woman who agrees to bear the child of the intending couple/woman by implantation of the embryo into her womb. Kindly refer to Section 2(zg) of the SRA. To be noted that the process of implantation must fall in line with the conditions set out under the Act.

(3) Section 4 (b) (IV) of the SRA

(4) Dutch Society of Obstetrics and Gynaecology Guidelines

(5) Surrogacy Arrangements Act, 1985

(6) Chapter 19, Children’s Act, 2005

(7) Article 1458, Greek Civil Code

2. Access and uptake of both legislations is limited only to married heterosexual couples and single women . Under the SR Act, intending couples are required to be between the ages of 23 to 50 if female and 26 to 55 if male, to be considered ‘eligible’ to avail surrogacy services . Additionally, the couple must demonstrate that they do not have any children, whether biological, adopted or through surrogacy, with the exception of a child who is physically/mentally challenged . Intending women on the other hand, must either be widows or divorcees aged between 35 to 45 years . ART Act, on the other hand, requires that the commissioning couple be an ‘infertile ’ married couple aged between the ages of 21 to 55 . Women, however, only have to be above the age of 21 to avail such services . This discrepancy fails to include within its ambit – single fathers, transgenders, live – in couples or couples falling outside the heteronormative purview. This discrimination is in violation of Article 14, as no reasonable restrictions have also been identified within the legislation. This goes against the very social fabric of a young nation, which now looks at sex and gender with a wider lens, than what the legislation presupposes it to abide by. Instances like this will cause more damage to the society at large, by diminishing their approach to the heteronormative roles only.

3. The ART Act restricts usage of sperm and oocyte of one donor to one commissioning couple alone and furthermore prohibits sale of human gametes , zygotes , and embryos both within the country and outside . Moreover, the Act, while limiting donation of sperm and oocyte to one couple, makes a special provision for the number of oocytes that can be retrieved from the female, but no such restrictions on the male . This provision not only becomes discriminatory but redundant because it clearly limits donation of gametes to one couple only.

4. As established under the SR Act, the National Registry, National/State Board and Appropriate (Central/State) derive their power/duties and responsibilities from the ART Act. Briefly, the National Registry is the central database consisting of details of all clinics and banks undertaking such services, facilities provided to patients thereby, and necessary outcomes of such aid provided. The National Board is tasked with assisting the central government in making reproductive technology-based policies, reviewing and monitoring implementation of both the legislations, formulating necessary rules, regulations, and codes of conduct to be followed by clinics and banks as well as overseeing the functioning of the bodies established under the SR A. The State Board, in turn, must

(8) Section 4(ii)(a) of SRA and Section 21(c)and (d) of the ART

(9) Refers to a couple having the medical indication requiring gestational surrogacy, aiming to become parents through surrogacy. Kindly refer to Section 2(r) of the SRA.

(10) Section 4(c) (I)of SRA

(11) Section 4(c)(II) of SRA

(12) Refers to a widow or divorces aiming to become a parent through surrogacy. Kindly refer to Section 2(s) of the SRA

(13) Section2(s) of SRA

(14) Refers to an infertile married couple seeking to obtain assisted reproductive technology related services from authorized banks or clinics. Kindly refer to Section 2(e) of the ART

(15) Inability to conceive after one year of unprotected coitus or other such medical conditions preventing the couples from conception – Section 2(j) of the ART

(16) Section 21(g) of the ART

(17) Section 2(u) of the ART

(18) Section 27(2) of the ART

(19) Refers to sperm and oocyte. Section 2(n) of SRA

(20) Refers to a fertilized oocyte. Section 2(zh) of SRA

(21) Refers to the developed organism after fertilization. Section 2(n) of SRA

(22) Exception on personal use subject to prior permission from the National Board. Kindly refer to Section 29 of the ART

(23) Section 27(4) of ART

ensure compliance of the directions and policies set out by the National Board and under the Acts. The Appropriate Authority is the certifying body. It has the authority to grant/suspend registration of clinics/banks, take legal action against those medical institutions who have failed to comply with the law, make recommendations to the State and National Board with respect to modification on rules and regulations and so on.

The requirement regarding maintenance of the National Registry may pose several issues, as the information received from donors, surrogates, intending couple/women and medical staff would invariably be in the nature of personal and sensitive personal data, particularly since the ART Act also mandates provision of Aadhar details of the donor. Firstly, the law has not provided for protection and security of such information stored and processed, which is a serious violation of privacy of individuals (as guaranteed under Article 21 of the Constitution) and also of the protection granted to such sensitive personal information under the Information Technology Act, 2000. In light of the fact that there is no proper legislation in the country governing the processing and usage of personal data, and the Personal Data Protection Bill, 2019 is lying in limbo before the Parliament, the gathering of such personal data under the legislation seems to be fraught with irregularities. Secondly, the ART Act goes beyond the decision of the Supreme Court in the Puttaswamy (2018) case, whereby the government was permitted to mandate use of Aadhaar authentication for beneficiaries only in relation to an expenditure on subsidy, benefit or service as provided under the Consolidated Fund of India . While we appreciate that with the upcoming health sector legislations concerning digital health, there is a cemented effort to preserve privacy; unless and until such backbone within the ecosystem (digital or physical) is created, it will be very difficult to ensure that a certain degree of privacy will be ensured/ warranted under these legislations.

5. Abortion under the SR Act is subject to written consent of the surrogate and subsequent authorization of the appropriate authority. No time period for such authorization has been specified, and it begets the question – why an individual’s right to body autonomy (a right under Article 21) has been subjected to government approval. This is also in stark contrast to non-surrogate women who do not require such permission when naturally pregnant with no clear justification for the discrimination, thereby being violative of the right to equality under Article 14 of the Constitution. Another area of concern is with regard to donor rights, since no provision/s to withdraw consent have been made available to such donors while such a right has been granted to commissioning couples . The legislature ought to have taken guidance from The Indian Council of Medical Research (ICMR), 2005 Guideline with respect to assisted reproductive technology and in its subsequent draft in 2014, which provides for provision of proper counselling to donors before the initiation of such process. The right to withdraw consent has also been provided under the 2006 Guideline and the 2014 Bill before implantation of the gamete/embryo into the uterus.

In all, the legislations have attempted to provide a structure to the sector, with clinics/banks mandatorily having to be registered, intending parties to be certified to avail such services, the bifurcation of duties between the Board are Appropriate Authority (both at a national and state level)

(24) Justice K.S Puttaswamy v. Union of India, Writ Petition (Civil) 494 of 2012, September 26,2018

(25) PRS, Issues for Consideration – Assisted Reproductive Technology (Regulation) Bill, 2021, Accessed online at https://prsindia.org/billtrack/prs-products/issues-for-consideration on 14.01.2022 at 2018 hours

(26) Supra at 17

(27) National Guidelines for Accreditation, Supervision &Regulation of ART Clinics in India, ICMR 2005

(28) Ethical Guidelines for Biomedical Research on Human Participants, ICMR 2006

(29) ART Bill 2014

to ensure proper implementation of the legislations, penalties in case of misuse or violation, and proper guidelines as to handling of such services by such medical professionals and institutions.

Keeping the practical aspects aside in terms of its implementation, the discrepancies highlighted herein may affect the very validity of the legislations, and it would be interesting to see if the Acts would withstand judicial scrutiny if challenged before any court of law. The aim should be to regulate the market from illegal transfer, black markets, and exploitation of women. The current legislations do not support these very causes, because of the inherent restrictions, strict compliance and consistent intervention. The question is whether having a poorly enacted legislation is preferable to allowing such practices to operate in a legislative vacuum.

Janavi Venkatesh, Associate

Janavi works as an Associate at TMT Law Practice. Having graduated from O.P Jindal Global University in August 2021, she has not only taken a great interest in Technology, Telecom and Intellectual Property Rights, but of Banking and Finance and Media Entertainment as well. She has garnered her experience and found her passion in TMT, through various internships, and also had the opportunity to draft/research on various aspects of Corporate, Technology, Telecom and Media laws.

 

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